Development and Production of Parenteral Dosage Forms for Clinical Studies

该项目的主要目的是开发和生产具有抗癌活性的有前途的新药物的药学上可接受的肠胃外剂型。NCI癌症治疗和诊断部（DCTD）癌症操作委员会选择的某些药物将被指定作为胃肠外产品（主要是无菌冻干产品）进行开发和生产。批量范围应从小批量（小于100个单位）到用于I期和II期试验的中等批量;但是，对于晚期II/III期试验，也可能增加到大批量（1 - 10，000个单位或更多）。开发和生产其他药物剂型（即大体积胃肠外制剂、无菌乳剂、脂质体和无菌微分散体）的能力是理想的，但不是必需的。 从本合同中获得的数据可1）用于支持美国国家癌症研究所向美国食品和药物管理局以及外国阿根提交的IND申请。2）提供给从事大规模剂型生产和这些剂型的分析评价的其他NCI承包商，和3）提供给医生、药剂师、护士，以及在临床环境中处理这些产品的其他医务人员。

The primary objective of this project is to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, Division of Cancer Treatment and Diagnosis (DCTD) Cancer Operating Committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes shall range from small batches (less than 100 units) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch sizes (1 - 10,000 or more units) for advanced Phase II/III trials is also possi¿ble. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenterals, sterile emulsions, liposomes and sterile micro-dispersions) is desirable but not essential. Data obtained from this contract may 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agen¿cies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting.